Fast Track Drugs Come to Market in the U.S. with FDA Cooperation

Despite exponential advances in biopharmaceutical knowledge and technology, biotech companies enduring the task of getting new drugs to market continue to face long timeframes, daunting costs and immense risks. By one count, of every 1,000 experimental drug compounds in some form of pre-clinical testing, only one makes it to clinical trials. Then, only one in five of those drugs make it to market. Of the drugs that get to market, only one in three bring in enough revenue to recover their costs. Meanwhile, the patent expiration clock is ticking—soon enough, manufacturers of generic alternatives steal market share from the firms that invested all that time and money in the development of the original drug.

Internet Research Tip:

You can review current and historical drug approval reports at the following page at the FDA. www.fda.gov/Drugs/InformationOnDrugs/default.htm

The FDA regulates biologic products for use in humans. It is a source of a broad variety of data on drugs, including vaccines, blood products, counterfeit drugs, exports, drug shortages, recalls and drug safety.

www.fda.gov/BiologicsBloodVaccines/default.htm

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